DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/12/2026 has been entered.
Response to Amendment
Currently claims 29, 31, 33, 38, 40, 42, and 48-61 are pending.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “human/animal or no human/animal” should be changed to “human or animal or not human or animal”. Appropriate correction is required.
Claim Interpretation
Regarding claim 29, the limitation “disabling display of the analysis results by the device and/or turning off a light source of the device if the collected signal is attributable to the device not being worn by the wearer” contains contingent limitations (see MPEP 2111.04) and has steps that includes steps that are not required to be performed because the conditions precedent are not met.
Specifically, if the collected signal determines that the device is being worn, then the disabling display and/or turning off a light of source step is not required, and only if the collected signal determines that the device is not being worn, then the disabling display and/or turning off a light source step is required.
Additionally the step of “determining whether or not the collected signal is attributable to the wearer being human/animal or not human/animal” also contains a contingent limitation. Specifically if it is determined that the wearer is not a human/animal, then the subsequent determining step regarding whether the device is being worn does not need to be performed. Conversely, if its determined that the collected signal is attributable to the wearer being human/animal, then the following determining step regarding whether the device is being worn may be performed.
As such, under the broadest reasonable interpretation, since the claimed invention may be practiced without either the condition for determining whether the wearer is human/animal being satisfied or the condition for disabling display being satisfied, the corresponding steps are not required by the claim. (see MPEP 2111.04).
Dependent claims 31, 33, 48-53, and 61 contain the same limitations as claim 29 and will also be also considered as such.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29, 31, 33, 38, 40, 42, and 48-61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 29, lines 3-12 recites “collecting a signal using the device; processing the collected signal to obtain analysis results; determining whether or not the collected signal is attributable to the wearer being human/animal or not human/animal; determining that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition by determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC) component of the collected signal; and disabling display of the analysis results by the device and/or turning off a light source of the device if the collected signal is attributable to the device not being worn by the wearer.” These limitations are directed to processing “a signal” to determine whether a device is being worn including: determining a mean and variance of a direct current component of the signal; and determining a variance of an alternating current component of the signal. Therefore the claim is drawn to a genus of signals having AC and DC components that are suitable for processing for determining device wear status.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice reduction to drawings or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (See MPEP 2163). However, the specification does not reasonably convey possession of this claimed genus.
Specifically, the specification consistently describes the signal as a photoplethysmography (PPG) signal, which includes a DC and an AC component, and further describes determining the mean/variance of these components for wrist-off detection. The specification does not describe other types of signals that possess such AC/DC components or that are processed using mean/variance in the same manner recited in the claim. Although an accelerometer (ACC) signal is disclosed, the ACC signal is used for motion detection and thresholding, and is not described as having AC/DC components let alone using mean/variance of those components for determining the device wear status.
As such, the specification fails the written description requirement by failing to demonstrate that the inventors were in possession of the claimed genus of “signal” as broadly recited, and instead only provide support for the narrower species of a PPG signal.
Regarding claim 38, lines 3-14 recites “a signal collection unit for collecting a signal; and a processor coupled to the signal collection unit for processing the collected signal to obtain analysis results and to determine whether or not the collected signal is attributable to the wearer being human/animal or not human/animal; wherein the processor is configured to determine that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition and for disabling display of the analysis results and/or turning off a light source of the device if the collected signal is attributable to the device not being worn by the wearer based on determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC) component of the collected signal.” Therefore the claim is drawn to a genus of signals having AC and DC components that are suitable for processing for determining device wear status.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice reduction to drawings or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (See MPEP 2163). However, the specification does not reasonably convey possession of this claimed genus.
Specifically, the specification consistently describes the signal as a photoplethysmography (PPG) signal, which includes a DC and an AC component, and further describes determining the mean/variance of these components for wrist-off detection. The specification does not describe other types of signals that possess such AC/DC components or that are processed using mean/variance in the same manner recited in the claim. Although an accelerometer (ACC) signal is disclosed, the ACC signal is used for motion detection and thresholding, and is not described as having AC/DC components let alone using mean/variance for determining the device wear status.
As such, the specification fails the written description requirement by failing to demonstrate that the inventors were in possession of the claimed genus of “signal” as broadly recited, and instead only provide support for the narrower species of a PPG signal.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the written description requirement of the claims they respectively depend upon.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29, 31, 33, 38, 40, 42, and 48-61 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 29, lines 5-6 recites the limitation “determining whether or not the collected signal is attributable to the wearer being human/animal or not human/animal” and “determining that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition by determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC) component of the collected signal”.
It is unclear how these two determining steps relate to one another, and what is ultimately being determined by the claimed method. Specifically, the first determining step appears to determine whether the wearer is human/animal or not human/animal, and the second determining step appears to determine whether the device is being worn by the wearer based on signal characteristics (mean/variance of AC/DC components).
However, the claim does not explain how the result of the first determining step is used, if at all, in the second determining step. As written there is an apparent disconnect between the first determining step and the rest of the method, rendering its purpose/use unclear.
Further, it is unclear what the mean/variance determination step is used for. Is it determining whether the device is being worn or if the wearer is human/animal or not human/animal. The second determining step appears to define the condition for determining whether the device is worn, which suggests that the first determining step is redundant, or the that the second determining is somehow intended to further define the first determining step but fails to do so.
For examination purposes, the step of “determining whether or not the collected signal is attributable to the wearer being human/animal or not human/animal is interpreted as part of the overall process of whether the device is being worn, such that the collected signal originates from a human/animal or not, and the following determining step is considered to determine whether the device is being worn based on the collected signal.
Regarding claim 38, lines 5-14 recites the limitation “determine whether or not the collected signal is attributable to the wearer being human/animal or not human/animal” and “wherein the processor is configured to determine that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition and for disabling display of the analysis results and/or turning off a light source of the device if the collected signal is attributable to the device not being worn by the wearer based on determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC) component of the collected signal.”
It is unclear how these two determining steps relate to one another, and what is ultimately being determined by the claimed method. Specifically, the first determining step appears to determine whether the wearer is human/animal or not human/animal, and the second determining step appears to determine whether the device is being worn by the wearer based on signal characteristics (mean/variance of AC/DC components).
However, the claim does not explain how the result of the first determining step is used, if at all, in the second determining step. As written there is an apparent disconnect between the first determining step and the rest of the method, rendering its purpose/use unclear.
Further, it is unclear what the mean/variance determination step is used for. Is it determining whether the device is being worn or if the wearer is human/animal or not human/animal. The second determining step appears to define the condition for determining whether the device is worn, which suggests that the first determining step is redundant, or the that the second determining is somehow intended to further define the first determining step but fails to do so.
For examination purposes, the step of “determining whether or not the collected signal is attributable to the wearer being human/animal or not human/animal is interpreted as part of the overall process of whether the device is being worn, such that the collected signal originates from a human/animal or not, and the following determining step is considered to determine whether the device is being worn based on the collected signal.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 29, 31, 33, 38, 40, 42, and 48-61 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract without significantly more.
Claim 29 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – The claim recites a method for controlling a wearable device for collecting physiological data of a wearer and is therefore a method.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “determining whether or not the collected signal is attributable to the wearer being human or animal human/animal or not human/animal; determining that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition by determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC) component of the collected signal”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Further, the limitations “determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC)” recite a mathematical concept.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim recites “A method of controlling a wearable device for collecting physiological data of a wearer, the method comprising: collecting a signal using the device; processing the collected signal to obtain analysis results; and disabling display of the analysis results by the device and/or turning off a light source of the device if the collected signal is attributable to the device not being worn by the wearer.” Collecting and processing data and then disabling a display or light are steps that merely amounts to pre-solution and post-solution insignificant activities.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception.
Claim 31 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – The claim recites a method for controlling a wearable device for collecting physiological data of a wearer and is therefore a method.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “determining a number of times the amplitude of the AC component is saturated, and a number of times the amplitude of the AC component is zero.”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 33 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons set forth in claim 29
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “calculating a signal to noise ratio of the collected signal”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 38 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – The claim recites a system for controlling a wearable device for collecting physiological data of a wearer and is therefore a machine.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “determine whether or not the collected signal is attributable to the wearer being human or animal human/animal or not human/animal; determine that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition by determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC) component of the collected signal”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Further, the claim limitations “determining a mean and a variance of a direct current (DC) component of the collected signal, and a variance of an alternating current (AC) component of the collected signal” recite a mathematical concept.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim recites “A wearable device for collecting physiological data of a wearer, the device comprising: a signal collection unit for collecting a signal using the device; a processor coupled to the signal collection unit for processing the collected signal to obtain analysis results; and disabling display of the analysis results by the device and/or turning off a light source of the device if the collected signal is attributable to the device not being worn by the wearer.” Collecting and processing data and then disabling a display or light are steps that merely amounts to pre-solution and post-solution insignificant activities.
These elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception.
Claim 40 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – for the same reasons set forth in claim 38.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “determining a number of times the amplitude of the AC component is saturated, and a number of times the amplitude of the AC component is zero.”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 42 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons set forth in claim 38.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “determine whether or not the collected signal is attributable to the device not being worn by the wearer based on calculating a signal to noise ratio of the collected signal”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 48 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 29.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein determining whether or not the collected signal is attributable to the device not being worn by the wearer comprises extracting one or more features from respective time windows of the collected data”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 49 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 31.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “determining, as a plurality of conditions, whether the means of the DC component is within a first range, whether the variance of the DC component is within a second range, whether the variance of the AC component is within a third range, and whether a sum of the number of times the amplitude of the AC component is saturated and the number of times the amplitude of the AC component is zero is lower than a first threshold, and determining that the device is not being worn by the wearer if any one of the plurality of conditions is not fulfilled”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Further, the limitation “a sum of the number of times the amplitude of the AC component is saturated” recites a mathematical concept.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 50 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 33.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the signal to noise ratio of the collected signal is determined in the frequency domain”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 51 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 33.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the signal to noise ratio of the collected signal is determined based on root mean square of the collected signal in a signal range and in a noise range, respectively”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 52 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 51.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein it is determined that the device is not worn if the root mean square in the signal range is not larger than a second threshold and/or the root mean square in the noise range is not larger than a third threshold.”
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Further, the claim limitation “the root mean square in the signal range is not larger than a second threshold and/or the root mean square in the noise range is not larger than a third threshold” recites a mathematical concept.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 53 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 33.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein it is determined that the device is not worn if the calculated signal to noise ratio is not larger than a fourth threshold.”
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 54 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 38.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the processor is configured to determine whether or not the collected signal is attributable to the device not being worn by the wearer based on extracting one or more features from respective time windows of the collected data.”
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 55 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 40.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the processor is configured to determine, as a plurality of conditions, whether the means of the DC component is within a first range, whether the variance of the DC component is within a second range, whether the variance of the AC component is within a third range, and whether a sum of the number of times the amplitude of the AC component is saturated and the number of times the amplitude of the AC component is zero is lower than a first threshold, and to determine that the device is not being worn by the wearer if any one of the plurality of conditions is not fulfilled”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Further, the claim limitation recites “a sum of the number of times the amplitude of the AC component is saturated and the number of times the amplitude of the AC component is zero is lower than a first threshold”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 56 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 42.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the signal to noise ratio of the collected signal is determined in the frequency domain”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 57 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 42.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the signal to noise ratio of the collected signal is determined based on root mean square of the collected signal in a signal range and in a noise range, respectively”.
This limitation, as drafted, is a process step, that, under its BRI, covers an abstract idea, more specifically a mathematical concept. That is, the listed claim recites a mathematical calculation that is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic equation such as exponentiation. Accordingly, the claim recites a mathematical concept-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 58 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 57.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the processor is configured to determine that the device is not worn if the root mean square in the signal range is not larger than a second threshold and/or the root mean square in the noise range is not larger than a third threshold”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 59 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 42.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the processor is configured to determine that the device is not worn if the calculated signal to noise ratio is not larger than a fourth threshold”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 60 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 54.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the processor is configured to determine whether or not the collected signal is attributable to the device not being worn by the wearer based on determining a number of times the amplitude of the AC component is saturated, and a number of times the amplitude of the AC component is zero”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim 61 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes – For the same reasons as set forth in claim 48.
Step 2A, Prong 1, Judicial Exception: Yes, the claim recites the limitation “wherein the processor is configured to determine whether or not the collected signal is attributable to the device not being worn by the wearer based on determining a number of times the amplitude of the AC component is saturated, and a number of times the amplitude of the AC component is zero”.
This limitation, as drafted, is a process step that, under its broadest reasonably interpretation (BRI), covers an abstract idea, more specifically a process that can be performed in the human mind. That is, nothing in the listed claim elements precludes the step from practically being performed in the mind and/or performed with the aid of a pen and paper, and/or performing the process in a computer environment. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A Prong 2, Integrated into Practical Application: No, the claim fails to recite addition claim elements.
Step 2B, Inventive Concept: No-Similarly to Step 2A, Prong 2, no additional claim elements are recited.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 29, 38, 48, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over by Creemers et al., (US20170296124A1) in view of Luan (US20200379545A1) and Klopfenstein et al., (US20080019218A1).
Regarding claim 29, Creemer teaches a method of controlling a wearable device for collecting physiological data of a wearer, the method comprising ([0046] wearable sensor device that comprises a heart rate monitor and can determine if the sensor device is currently being worn):
collecting a signal using the device (fig. 2 heart rate monitor comprises a PPG sensor with a light emitter 20 and detector 22 [0054]);
processing the collected signal to obtain analysis results ([0103] the system has a processor for processing the sensed data and implementing the algorithm);
determining whether or not the collected signal is attributable to the wearer being human/animal or not human/animal ([0014] the processor uses the heart rate monitor and motion sensor to determine if the device is being worn or not); and
determining that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition ([0067] light detector has two light level thresholds, and when L=0 the device is not worn);
disabling a component of the analysis results by the device if the collected signal is attributable to the device not being worn by the wearer ([0080]-[0081] when it is determined the device is not worn, the sensors are turned off).
However, Creemers fails to explicitly disclose determining a mean and a variance of a direct current (DC) component of the collected signal.
In the same light field of endeavor, Luan determining a mean and a variance of a direct current (DC) component of the collected signal ([0059] the wearable device takes the mean of the light intensities, which represents the DC component of the signal, of the reflected light and the wearing state of the device is judged; [0017] the variance of light intensities is judged to see if it less than a preset threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the mean and variance of the light intensities of Luan, as this would allow for the reduction of misjudgment (see Luan [0038]).
However, the combination of references still fail to explicitly disclose a variance of an alternating current (AC) component of the collected signal, and disabling a display if the collected signal is attributable to the device not being worn by the wearer.
In the same wearable device field of endeavor, Klopfenstein teaches a variance of an alternating current (AC) component of the collected signal ([0059] the alternating components of each pulse signal P1, P2, P3, etc., takes into account variance to determine if the device is on the wrist or not being worn), and disabling a display if the collected signal is attributable to the device not being worn by the wearer ([0047] if the display may be suspended if the reliability index is insufficient; [0060] the reliability index is insufficient in situations such as when the device is not being worn).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the determination of whether the device is being worn or not of Creemers with the incorporation of using variance of an alternating component of Klopfenstein, as this would avoid displaying unrealistic pulse values (see Klopfenstein [0015]).
Regarding claim 38, Creemer teaches a wearable device for collecting physiological data of a wearer, the device comprising ([0046] wearable sensor device that comprises a heart rate monitor and can determine if the sensor device is currently being worn):
a signal collection unit for collecting a signal (fig. 2 heart rate monitor comprises a PPG sensor with a light emitter 20 and detector 22 [0054]);
a processor coupled to the signal collection unit (fig. 4 circuit 20 processes the measurements [0027]) for processing the collected signal to obtain analysis results ([0103] the system has a processor for processing the sensed data and implementing the algorithm) and to determine whether or not the collected PPG signal is attributable to the wearer being human/animal or not human/animal ([0014] the processor uses the heart rate monitor and motion sensor to determine if the device is being worn or not); and
wherein the processor is configured to determine that the device is not being worn by the wearer if information only about the collected signal does not fulfill at least one condition ([0069] the heart rate monitor has a heart rate threshold that is used to help determine if the device is being worn ; HR=0 is an indication that the heart rate is below the threshold (or there is no detected heart rate at all) and HR=1 is an indication that the heart rate is above the threshold. The threshold is for example 125 BPM; In other words, heart rate is determined by the collected PPG signal obtained through the pulses in the PPG signal ([0049], heart rate is also of multiple cardiac cycles, and the heart is rate is determined to be either worn or not worn depending on the threshold, of which is a range, i.e., HR=0 when the heart rate is 0-125 and HR=1 when the heart rate is 125-∞) for disabling a component of the analysis results by the device if the collected signal is attributable to the device not being worn by the wearer ([0080]-[0081] when it is determined the device is not worn, the sensors are turned off).
However, Creemers fails to explicitly disclose determining a mean and a variance of a direct current (DC) component of the collected signal.
In the same light field of endeavor, Luan determining a mean and a variance of a direct current (DC) component of the collected signal ([0059] the wearable device takes the mean of the light intensities, which represents the DC component of the signal, of the reflected light and the wearing state of the device is judged; [0017] the variance of light intensities is judged to see if it less than a preset threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the mean and variance of the light intensities of Luan, as this would allow for the reduction of misjudgment (see Luan [0038]).
However, the combination of references still fail to explicitly disclose a variance of an alternating current (AC) component of the collected signal, and disabling a display if the collected signal is attributable to the device not being worn by the wearer.
In the same wearable device field of endeavor, Klopfenstein teaches a variance of an alternating current (AC) component of the collected signal ([0059] the alternating components of each pulse signal P1, P2, P3, etc., takes into account variance to determine if the device is on the wrist or not being worn), and disabling a display if the collected signal is attributable to the device not being worn by the wearer ([0047] if the display may be suspended if the reliability index is insufficient; [0060] the reliability index is insufficient in situations such as when the device is not being worn).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the determination of whether the device is being worn or not of Creemers with the incorporation of using variance of an alternating component of Klopfenstein, as this would avoid displaying unrealistic pulse values (see Klopfenstein [0015]).
Regarding claim 48, modified Creemers teaches the method of claim 29, wherein Creemers further teaches wherein determining whether or not the collected signal is attributable to the device not being worn by the wearer comprises extracting one or more features from respective time windows of the collected data ([0021] the data is acquired in a pre-determined time period to determine the sensor device is not being worn).
Regarding claim 54, modified Creemers teaches the device of claim 38, wherein Creemers further teaches wherein determining whether or not the collected signal is attributable to the device not being worn by the wearer comprises extracting one or more features from respective time windows of the collected data ([0021] the data is acquired in a pre-determined time period to determine the sensor device is not being worn).
Claims 31, 40, 49, 55, 60, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over by Creemers in view of Luan and Klopfenstein as applied to claim 29, 38, 54, and 48, and further in view of Li et al., “Dynamic time warping and machine learning for signal quality assessment of pulsatile signals” 2012 Physiol. Meas. 33 1491 (hereinafter “Li”) and Saraogi (WO2016157217A2).
Regarding claim 31, modified Creemers teaches the method of claim 29, wherein Creemers further teaches wherein determining whether or not the collected signal is attributable to the device not being worn by the wearer ([0014] the processor uses the heart rate monitor and motion sensor to determine if the device is being worn or not) but fails to explicitly disclose determining a number of times the amplitude of the AC component is saturated.
In the same ppg field of endeavor, Li teaches determining a number of times the amplitude of the AC component is saturated (pg. 3 an algorithm is employed to detect the percentage of saturation of a max/minimum value within each beat).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the algorithm of Li, as this would result in improved estimates of derived physiological parameters (see Li page 11).
However, the combination of references are silent regarding a number of times the amplitude of the AC component is zero.
In the same PPG field of endeavor, Saraogi teaches a number of times the amplitude of the AC component is zero (pg. 24 lines 18-25 the system detects how many times the pulsatile signal is not present (and therefore an amplitude of zero) to check if the device is not on the body).
It would have been obvious to one of ordinary skill in the art to modify the determination process of modified Creemers with the pulsatile failure detection process of Saraogi, as this would allow for longer battery life due to the number of failures being able to manage battery consumption (see Saraogi pg. 24 lines 23-25).
Regarding claim 40, modified Creemers teaches the device of claim 38, wherein Creemers further teaches wherein determining whether or not the collected signal is attributable to the device not being worn by the wearer ([0014] the processor uses the heart rate monitor and motion sensor to determine if the device is being worn or not) but fails to explicitly disclose determining a number of times the amplitude of the AC component is saturated.
In the same ppg field of endeavor, Li teaches determining a number of times the amplitude of the AC component is saturated (pg. 3 an algorithm is employed to detect the percentage of saturation of a max/minimum value within each beat).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the algorithm of Li, as this would result in improved estimates of derived physiological parameters (see Li page 11).
However, the combination of references are silent regarding a number of times the amplitude of the AC component is zero.
In the same PPG field of endeavor, Saraogi teaches a number of times the amplitude of the AC component is zero (pg. 24 lines 18-25 the system detects how many times the pulsatile signal is not present (and therefore an amplitude of zero) to check if the device is not on the body).
It would have been obvious to one of ordinary skill in the art to modify the determination process of modified Creemers with the pulsatile failure detection process of Saraogi, as this would allow for longer battery life due to the number of failures being able to manage battery consumption (see Saraogi pg. 24 lines 23-25).
Regarding claim 49, modified Creemers teaches the method of claim 31, wherein Creemers further teaches wherein the process is configured to determine a plurality of conditions to determine that the device is not being worn by the wearer if any one of the conditions is not fulfilled (fig.3 light thresholds, heart rate thresholds, activity levels may be conditions, and if for example light is 0 then the device may be not worn [0061]-[0090]) but fails to explicitly disclose the mean of the DC component is within a first range, and whether the variance of the DC component is within a second range.
In the same light field of endeavor, Luan teaches the mean of the DC component is within a first range ([0059] the wearable device takes the mean of the light intensities of the reflected light and the wearing state of the device is judged) and whether the variance of the DC component is within a second range ([0017] the variance of light intensities is judged to see if it less than a preset threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the mean and variance of the light intensities of Luan, as this would allow for the reduction of misjudgment (see Luan [0038]).
However, the combination of references still fails to explicitly disclose whether a sum of the number of times the amplitude of the AC component is saturated.
In the same ppg field of endeavor, Li teaches determining a number of times the amplitude of the AC component is saturated (pg. 3 an algorithm is employed to detect the percentage of saturation of a max/minimum value within each beat).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the algorithm of Li, as this would result in improved estimates of derived physiological parameters (see Li page 11).
However, the combination of references are silent regarding a number of times the amplitude of the AC component is zero.
In the same PPG field of endeavor, Saraogi teaches a number of times the amplitude of the AC component is zero (pg. 24 lines 18-25 the system detects how many times the pulsatile signal is not present (and therefore an amplitude of zero) to check if the device is not on the body).
It would have been obvious to one of ordinary skill in the art to modify the determination process of modified Creemers with the pulsatile failure detection process of Saraogi, as this would allow for longer battery life due to the number of failures being able to manage battery consumption (see Saraogi pg. 24 lines 23-25).
Regarding claim 55, modified Creemers teaches the device of claim 40, wherein Creemers further teaches wherein the process is configured to determine a plurality of conditions to determine that the device is not being worn by the wearer if any one of the conditions is not fulfilled (fig.3 light thresholds, heart rate thresholds, activity levels may be conditions, and if for example light is 0 then the device may be not worn [0061]-[0090]) but fails to explicitly disclose the mean of the DC component is within a first range, and whether the variance of the DC component is within a second range.
In the same light field of endeavor, Luan teaches the mean of the DC component is within a first range ([0059] the wearable device takes the mean of the light intensities of the reflected light and the wearing state of the device is judged) and whether the variance of the DC component is within a second range ([0017] the variance of light intensities is judged to see if it less than a preset threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the mean and variance of the light intensities of Luan, as this would allow for the reduction of misjudgment (see Luan [0038]).
However, the combination of references still fails to explicitly disclose whether a sum of the number of times the amplitude of the AC component is saturated.
In the same ppg field of endeavor, Li teaches determining a number of times the amplitude of the AC component is saturated (pg. 3 an algorithm is employed to detect the percentage of saturation of a max/minimum value within each beat).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the algorithm of Li, as this would result in improved estimates of derived physiological parameters (see Li page 11).
However, the combination of references are silent regarding a number of times the amplitude of the AC component is zero.
In the same PPG field of endeavor, Saraogi teaches a number of times the amplitude of the AC component is zero (pg. 24 lines 18-25 the system detects how many times the pulsatile signal is not present (and therefore an amplitude of zero) to check if the device is not on the body).
It would have been obvious to one of ordinary skill in the art to modify the determination process of modified Creemers with the pulsatile failure detection process of Saraogi, as this would allow for longer battery life due to the number of failures being able to manage battery consumption (see Saraogi pg. 24 lines 23-25).
Regarding claim 60, modified Creemers teaches the device of claim 54, wherein Creemers further teaches wherein determining whether or not the collected signal is attributable to the device not being worn by the wearer ([0014] the processor uses the heart rate monitor and motion sensor to determine if the device is being worn or not) but fails to explicitly disclose determining a number of times the amplitude of the AC component is saturated.
In the same ppg field of endeavor, Li teaches determining a number of times the amplitude of the AC component is saturated (pg. 3 an algorithm is employed to detect the percentage of saturation of a max/minimum value within each beat).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Creemers with the algorithm of Li, as this would result in improved estimates of derived physiological parameters (see Li page 11).
However, the combination of references are silent regarding a number of times the amplitude of the AC component is zero.
In the same PPG field of endeavor, Saraogi teaches a number of times the amplitude of the AC component is zero (pg. 24 lines 18-25 the system detects how many times the pulsatile signal is not present (and therefore an amplitude of zero) to check if the device is not on the body).
It would have been obvious to one of ordinary skill in the art to modify the determination process of modified Creemers with the pulsatile failure detection process of Saraogi, as this would allow for longer battery life due to the number of failures being able to manage battery consumption (see Saraogi pg. 24 lines 23-25).
Regarding claim 61, modified Creemers teaches the method of claim 48, wherein Creemers further teaches wherein determining whether or not the collected signal is attributable to the device not being worn by the wearer ([0014] the processor uses the heart rate monitor and motion sensor to determine if the device is being worn or not) but fails to explicitly disclose determining a number of times the amplitude of the AC component is saturated.
In the same ppg field of endeavor, Li teaches determining a number of times the amplitude of the AC component is saturated (pg. 3 an algorithm is employed to detect the percentage of saturation of a max/minimum value within each beat).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the algorithm of Li, as this would result in improved estimates of derived physiological parameters (see Li page 11).
However, the combination of references are silent regarding a number of times the amplitude of the AC component is zero.
In the same PPG field of endeavor, Saraogi teaches a number of times the amplitude of the AC component is zero (pg. 24 lines 18-25 the system detects how many times the pulsatile signal is not present (and therefore an amplitude of zero) to check if the device is not on the body).
It would have been obvious to one of ordinary skill in the art to modify the determination process of modified Creemers with the pulsatile failure detection process of Saraogi, as this would allow for longer battery life due to the number of failures being able to manage battery consumption (see Saraogi pg. 24 lines 23-25).
Claims 33 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over by Creemers in view of Luan and Klopfenstein as applied to claim 29 and 38, respectively, and further in view of Cheong et al., (US20150293592A1).
Regarding claim 33, Creemers teaches the method of claim 29, but fails to explicitly disclose determining whether or not the collected PPG signal is attributable to the device not being worn by the wearer comprises calculating a signal to noise ratio of the collected PPG signal.
In the same physiological measuring field of endeavor, Cheong teaches determining whether or not the collected PPG signal is attributable to the device not being worn by the wearer comprises calculating a signal to noise ratio of the collected PPG signal ([0432] the device determines if it is in a normal wearing state by seeing if the signal-to-noise ratio for the detected PPG signal a period is greater than a specific value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the method of Creemers with the SNR information of Cheong, as both inventions relate to determining if the device is in its normal wearing state, and would yield the predictable result of the method additionally using SNR to determine if the device is being worn to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of the method of Creemers also use SNR to determine if the device is being worn are reasonably predictable.
Regarding claim 42, Creemers teaches the device of claim 38, but fails to explicitly disclose determining whether or not the collected PPG signal is attributable to the device not being worn by the wearer comprises calculating a signal to noise ratio of the collected PPG signal.
In the same physiological measuring field of endeavor, Cheong teaches determining whether or not the collected PPG signal is attributable to the device not being worn by the wearer comprises calculating a signal to noise ratio of the collected PPG signal ([0432] the device determines if it is in a normal wearing state by seeing if the signal-to-noise ratio for the detected PPG signal a period is greater than a specific value).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the method of Creemers with the SNR information of Cheong, as both inventions relate to determining if the device is in its normal wearing state, and would yield the predictable result of the method additionally using SNR to determine if the device is being worn to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of the method of Creemers also use SNR to determine if the device is being worn are reasonably predictable.
Claims 50 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over by Creemers in view of Luan, Klopfenstein, and Cheong as applied to claim 33 and 42, respectively, and further in view of Gu et al., (US20190357850A1).
Regarding claim 50, modified Creemers teaches the method of claim 33, but fails to explicitly disclose wherein the signal to noise ratio of the collected signal is determined in the frequency domain.
In the same PPG field of endeavor, Gu teaches wherein the signal to noise ratio of the collected signal is determined in the frequency domain ([0109] the signal to noise ratio of the frequency domain data is processed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the calculation of the SNR of modified Creemers to calculate the SNR of frequency domain as taught by Gu, as this would improve the detection accuracy (see Gu [0108]).
Regarding claim 56, modified Creemers teaches the device of claim 42, but fails to explicitly disclose wherein the signal to noise ratio of the collected signal is determined in the frequency domain.
In the same PPG field of endeavor, Gu teaches wherein the signal to noise ratio of the collected signal is determined in the frequency domain ([0109] the signal to noise ratio of the frequency domain data is processed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the calculation of the SNR of modified Creemers to calculate the SNR of frequency domain as taught by Gu, as this would improve the detection accuracy (see Gu [0108]).
Claims 51 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over by Creemers in view of Luan, Klopfenstein, and Cheong as applied to claim 33 and 42, respectively, and further in view Fathieh et al., (US20210212582A1).
Regarding claim 51, modified Creemers teaches the method of claim 33, but fails to explicitly disclose wherein the signal to noise ratio of the collected signal is determined based on root mean square of the collected signal in a signal range and in a noise range, respectively.
In the same PPG field of endeavor, Fathieh teaches wherein the signal to noise ratio of the collected signal is determined based on root mean square of the collected signal in a signal range and in a noise range, respectively ([0247] the SNR equation is based on the RMS of the signal and the noise).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application apply the technique of the SNR equation of Fathieh to the SNR calculation of modified Creemers, as both inventions relate to calculating processing PPG signals, and would yield the predictable result of a PPG processing device calculating SNR using the RMS of the signal and the noise to one of ordinary skill. One of ordinary skill would be able to apply such a technique, and the results of modified Creemers calculating SNR using RMS of signal and noise are reasonably predictable.
Regarding claim 57, modified Creemers teaches the device of claim 42, but fails to explicitly disclose wherein the signal to noise ratio of the collected signal is determined based on root mean square of the collected signal in a signal range and in a noise range, respectively.
In the same PPG field of endeavor, Fathieh teaches wherein the signal to noise ratio of the collected signal is determined based on root mean square of the collected signal in a signal range and in a noise range, respectively ([0247] the SNR equation is based on the RMS of the signal and the noise).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application apply the technique of the SNR equation of Fathieh to the SNR calculation of modified Creemers, as both inventions relate to calculating processing PPG signals, and would yield the predictable result of a PPG processing device calculating SNR using the RMS of the signal and the noise to one of ordinary skill. One of ordinary skill would be able to apply such a technique, and the results of modified Creemers calculating SNR using RMS of signal and noise are reasonably predictable.
Claims 52 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over by Creemers in view of Klopfenstein, Cheong, and Fathieh as applied to claim 51 and 58, respectively, and further in view Roovers et al., (US20170215747A1).
Regarding claim 52, modified Creemers teaches the method of claim 51, but fails to explicitly disclose wherein it is determined that the device is not worn if the root mean square in the signal range is not larger than a second threshold.
In the same PPG field of endeavor, Roovers teaches wherein it is determined that the device is not worn if the root mean square in the signal range is not larger than a second threshold ([0050] the off-skin detection unit 130 has the RMS of the signal data is computed, and if the RMS of the first buffer is smaller than the RMS of the second buffer, the PPG sensors are switched).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers to take the RMS of the signal, as this would provide a reliable way to detect if the sensor/device is off of the skin (see Roovers [0051]).
Regarding claim 58, modified Creemers teaches the method of claim 57, but fails to explicitly disclose wherein it is determined that the device is not worn if the root mean square in the signal range is not larger than a second threshold.
In the same PPG field of endeavor, Roovers teaches wherein it is determined that the device is not worn if the root mean square in the signal range is not larger than a second threshold ([0050] the off-skin detection unit 130 has the RMS of the signal data is computed, and if the RMS of the first buffer is smaller than the RMS of the second buffer, the PPG sensors are switched).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Creemers to take the RMS of the signal, as this would provide a reliable way to detect if the sensor/device is off of the skin (see Roovers [0051])
Claims 53 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over by Creemers in view of Luan, Klopfenstein, and Cheong as applied to claims 33 and 42, respectively, and further in view of Ko et al., (US 20210110019 A1).
Regarding claims 53, modified Creemers teaches the method of claim 33, but fails to explicitly disclose wherein it is determined that the device is not worn if the calculated signal to noise ratio is not larger than a fourth threshold.
However, in the same PPG field of endeavor, Ko teaches wherein it is determined that the device is not worn if the calculated signal to noise ratio is not larger than a fourth threshold ([0033] If the calculated SNR is lower than a threshold, the device is not adjacent to the skin surface, and therefore not worn).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Creemers with the SNR ratio threshold of Ko, as this help improve confidence of the detected result (see Ko [0077]).
Regarding claims 59, modified Creemers teaches the device of claim 42, but fails to explicitly disclose wherein it is determined that the device is not worn if the calculated signal to noise ratio is not larger than a fourth threshold.
However, in the same PPG field of endeavor, Ko teaches wherein it is determined that the device is not worn if the calculated signal to noise ratio is not larger than a fourth threshold ([0033] If the calculated SNR is lower than a threshold, the device is not adjacent to the skin surface, and therefore not worn).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Creemers with the SNR ratio threshold of Ko, as this help improve confidence of the detected result (see Ko [0077]).
Response to Arguments
Applicant’s arguments with respect to claims 29 and 38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The remaining dependent claims are rejected for the same reasons as above
Conclusion
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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